On March 30, 2020, CMS issued additional Section 1135 blanket waivers to provide the American healthcare system with additional flexibility to respond to the COVID-19 pandemic. CMS is authorized under Section 1135 of the Social Security Act, to waive certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements and conditions of participation, as a result of the President’s declaration of a national emergency, coupled with Secretary Azar’s earlier declaration of a public health emergency (PHE) in accordance with Section 319 of the Public Health Service Act. These regulatory changes are effective retroactively to March 1st and will apply across the US healthcare system for the entirety of the emergency declaration. CMS additionally issued the interim final rule (IFR), Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, detailing changes to telehealth, billing and payment and other requirements. The IFC may be found here.
CMS has updated its website to include fact sheets regarding the 1135 blanket waivers, which are now organized by provider type. The fact sheets may be found here. CMS’s recent actions provide for the following:
Increased Hospital Capacity
Under normally applicable federal requirements, hospitals must provide services within their own buildings. The temporary waivers enable hospitals and health systems to provide healthcare services at other non-hospital buildings and spaces, such as ambulatory surgical centers (ASCs), inpatient rehabilitation hospitals, hotels and dormitories. ASCs can temporarily enroll as hospitals and provide hospital services to address the need to increase hospital capacity. Other relevant entities, such as freestanding emergency departments, can additionally pursue enrollment as an ASC and then convert their enrollment to that of a hospital during the PHE. These entities may enroll and bill as hospitals during the PHE, unless inconsistent with their State’s Emergency Preparedness or Pandemic Plan.
Ambulances are now permitted to transport patients to a multitude of locations where transportation would not normally be deemed medically appropriate. Ambulances may transport patients to any destination which is able to provide treatment to the patient in a manner that is consistent with state and local Emergency Medical Services protocols where the services are being furnished.
Home Testing
Medicare will now pay laboratory technicians to travel to a beneficiary’s home to collect specimens for COVID-19 testing. Medicare will additionally cover the specimen collection fee.
Increased Flexibilities for Dialysis Facilities
42 CFR 494.180(d) requires dialysis facilities to provide services on its main premises or contiguous premises. Dialysis facilities can now provide services to patients in nursing homes or skilled nursing facilities for the duration of the PHE. Dialysis facilities may additionally establish special purpose facilities to care for patients with COVID-19. CMS is waiving the “on-time” requirements for initial and follow-up comprehensive assessments of patients and has waived certain emergency preparedness and equipment maintenance and fire safety inspections.
Increased Flexibilities for Hospice Care
CMS has waived the requirement that hospices use volunteers and the requirement for hospices to provide certain non-core hospice services during the national emergency, such as physical, occupational and speech-language therapies. CMS is additionally extending the timeframes for hospices to complete their assessments of patients and is waiving requirements for onsite visits to determine if aides are providing care consistent with the care plan. Hospice providers can provide services to Medicare patients through telehealth if it is feasible and appropriate to do, such as the face-to-face physician visit that is necessary for recertification.
Blanket Waivers of Sanctions under the Physician Self-Referral Law (Stark Law)
CMS issued blanket waivers of sanctions under the federal physician self-referral law (the Stark Law) related to certain activities for purposes of responding to the COVID-19 pandemic (collectively, the Stark Waivers). The Stark Waivers are effective retroactively to March 1, 2020, apply nationwide, and may be used without notifying CMS. Providers that wish to use a Stark Waiver to protect an otherwise prohibited financial relationship or referral must satisfy all conditions of the waiver to avoid triggering the Stark Law’s sanctions.
The Stark Waivers apply only to financial relationships and referrals related to specified “COVID-19 Purposes” (e.g., increasing capacity, providing diagnosis or treatment, securing professional services). Where a financial relationship or referral is for a COVID-19 Purpose, CMS is waiving the sanctions for noncompliance with the requirements specified in the Stark Waivers. This means CMS will permit certain referrals and the submission of related claims that would otherwise violate the Stark Law. The Stark Waivers are available here. A more detailed explanation about the Stark Waivers is available here.
Expansion of the Healthcare Workforce
CMS has issued numerous waivers to enable healthcare systems to rapidly expand their workforce. For teaching hospitals, medical residents will have more flexibility to provide services under the direction of a teaching physician. During the PHE, teaching physicians can now provide supervision virtually using audio/video communication technology.
CMS is additionally waiving requirements to allow for physicians whose privileges are about to expire to continue practicing at the hospital, and for new physicians to begin practicing in the hospital before the medical staff and governing body have given approval. CMS has additionally waived the requirement that a certified registered nurse anesthetist (CRNA) perform services under the supervision of a physician. Further, hospitals are no longer required to designate in writing the personnel qualified to perform specific respiratory care procedures.
Pursuant to 42 CFR 482.12(c), Medicare patients must normally be under the care of a physician. CMS has issued waivers permitting hospitals to use other practitioners, such as physician assistants and nurse practitioners, to the fullest extent possible, in accordance with a state’s emergency preparedness or pandemic plan.
Expansion of Telehealth Services
To mitigate the risk of the spread of the coronavirus, CMS is continuing to expand access to telehealth services for Medicare patients. CMS will now allow for more than 80 additional services to be furnished via telehealth. A complete list of covered telehealth services may be found here. Clinicians can provide remote patient monitoring services to both new and established patients suffering from acute or chronic conditions. Remote patient monitoring can now be used for patients with only one disease.
Previously, Virtual Check-In services, where a patient and a doctor have a brief check-in regarding the patient’s health, could only be provided to patients that had an established relationship with the physician. Doctors are now permitted to provide these services to both new and established patients.
Home Health Agencies can provide services to beneficiaries using telehealth within the 30-day episode of care, as long as it’s part of the patient’s plan of care and does not replace needed in-person visits as ordered by the plan of care.
CMS is further enabling clinicians to provide remote patient monitoring services to patients with acute and chronic conditions. Providers are now permitted to evaluate beneficiaries who have audio phones, only. In addition, CMS is allowing physicians to supervise their clinical staff using virtual technologies, instead of requiring in-person presence.
Reprioritization of PACE, Medicare Parts C and D Program and RADV Audits
CMS is reprioritizing scheduled program audits for Medicare Advantage organizations, Part D sponsors, Medicare-Medicaid Plans and PACE organizations. CMS will prioritize investigation and resolution of instances of noncompliance where the health and safety of beneficiaries are at serious risk and complaints alleging infection control concerns.
CMS is additionally suspending Risk Adjustment Data Validation (RADV) activities related to the payment year 2015 audit and will not initiate any additional contract-level audits until after the PHE has ended. Organizations are instructed to suspend solicitation of RADV-related medical records from providers.
Changes to “Paperwork” Requirements
CMS has implemented changes to numerous “paperwork” requirements to encourage and allow clinicians to spend more time with patients. For example, while the PHE is in effect, hospitals are not required to have written policies regarding visitation rights for patients in COVID-19 isolation, do not have to provide information about its advance directive policies to patients, and will have more time to provide patients with a copy of their medical record.
CMS is additionally expanding its current Accelerated and Advance Payments Program to address potential disruptions in claims submissions and processing. CMS is authorized to provide accelerated or advance payments during the PHE to any Medicare provider or supplier who submits a request to the appropriate Medicare Administrative Contractor (MAC) and meets the specific qualifications. Each MAC will work to review the requests and issue payments within seven calendar days of receiving the requests. Additional details regarding the Accelerated and Advance Payments Program may be found here.
CMS is additionally removing limitations set by National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs), that cover respiratory related devices. The current NCDs and LCDs that restrict coverage of these devices and services to patients with particular clinical characteristics no longer apply during the PHE. Medicare will therefore cover non-invasive ventilators, respiratory assist devices and continuous positive airway pressure devices based on the clinician’s assessment of the patient.
In addition to providing new blanket waivers, CMS has additionally continued to evaluate and approve individual State Medicaid 1135 waiver requests. All Section 1135 approval letters can be found here.
